Events

Recall of Titanium Orthos Bracket

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ormco Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0309-05
  • Event Initiated Date
    2004-11-18
  • Event Date Posted
    2004-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36026
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bracket, Metal, Orthodontic - Product Code EJF
  • Reason
    Misassembly. stainless steel and titanium parts were mistakenly welded together to construct the device. the weld failed.
  • Action
    Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.

Device

Titanium Orthos Bracket
  • Model / Serial
    Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.
  • Product Description
    Titanium Orthos Bracket
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation
  • Manufacturer Address
    Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Source
    USFDA